Weight Loss in Adults Over 50 with Obesity

Not Applicable

Completed

Interventions: Behavioral: High Protein Diet
Behavioral: Resistance Training

Brief Summary: The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men \>50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).

Recruitment & Eligibility

Inclusion Criteria

Male or Female
Age ≥50 years
Post-menopausal if Female
BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
Ambulatory with or without a walking device or use of a manual wheelchair for mobility.

Exclusion Criteria

Untreated hyper or hypothyroidism.
Cancer (except basal cell).
Gastrointestinal disorders affecting food intake.
<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
Uses a powered wheelchair for mobility.
Has a pacemaker or any other life-sustaining medical implant.

Arm && Interventions

Group	Intervention	Description
High Protein Diet	High Protein Diet	Enrollment in State of Slim (SOS) weight loss program with a high protein diet.
Resistance Training	Resistance Training	Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions.

Primary Outcome Measures

Name	Time	Method
Class Attendance	Baseline through week 52.	Class Attendance will be tracked to determine clinical trial feasibility.
2nd Stage Intervention Preference	Week 8	Participant preferences for 2nd stage interventions will be measured at week 8 by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
Recruitment and Retention Rates	Baseline through week 52.	Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
1st Stage Intervention Preference	Baseline	Participant preferences for 1st stage interventions will be measured at baseline by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
1st Stage Treatment Credibility	Baseline.	Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
2nd Stage Treatment Credibility	Week 8.	Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Body Weight	Baseline, Weeks 8, 16, and 52	Changes from baseline body weight will be measured at weeks 8, 16, and 52.
Fat mass	Baseline, Weeks 8, 16, and 52	Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
Fat free mass	Baseline, Weeks 8, 16, and 52	Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.

Locations (1): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States

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